| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K153571 |
08/23/2016 |
Cavilon Advanced High Endurance Skin Protectant |
3M HEALTH CARE |
MARIA RUIZ |
| K153731 |
08/25/2016 |
LifeFlow Rapid Infusion Device (LifeFlow Device) |
410 Medical Innovation, LLC |
Galen Robertson |
| K161403 |
08/16/2016 |
A.R.C. Laser Surgical Fibers and Probes |
A.R.C. LASER GMBH |
ANGELA THYZEL |
| K153744 |
08/04/2016 |
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) |
A1 GLOVE SDN BHD |
CONNIE YUNG |
| K161874 |
08/10/2016 |
Audit MicroControls Linearity DROP LQ Blood Glucose |
AALTO SCIENTIFIC, LTD. |
ROBERT BURDA |
| K161240 |
08/10/2016 |
Rhythm View Workstation (non-streaming) |
Abbott Electrophysiology |
Dennis Pozzo |
| K153375 |
08/12/2016 |
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls |
ABBOTT LABORATORIES |
LAURA YELVIGI JOGLEKAR |
| K161985 |
08/07/2016 |
Steerable Guide Catheter |
ABBOTT VASCULAR |
Makena Mc Gowan |
| K153559 |
08/26/2016 |
OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System |
Accelerated Care Plus (ACP) |
Patrick Parker |
| K161278 |
08/08/2016 |
Cerafix Dura Substitute |
ACERA SURGICAL, INC. |
Matthew MacEwan |
| K152135 |
08/09/2016 |
Quantitative Electrocardiographic Detector (QED 2000) |
ACME Portable Machines, Inc. |
James Cheng |
| K161867 |
08/05/2016 |
On Call Pro Blood Glucose Monitoring System |
ACON LABORATORIES |
Qiyi Xie |
| K161445 |
08/16/2016 |
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C |
ADAPTA MEDICAL, INC |
Adrian Elfe |
| K160239 |
08/10/2016 |
TAP 3, TAP 1 |
Airway Management, Inc. |
Dale Siebenmorgen |
| K161375 |
08/18/2016 |
Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit |
ALERE SCARBOROUGH, INC. |
Ashley Lucas |
| K160075 |
08/17/2016 |
Accent XL |
Alma Lasers Inc. |
Avi Farbstein |
| K160646 |
08/24/2016 |
XYcor« Expandable Spinal Spacer System |
Alphatec Spine, Inc |
Renee Murphy |
| K153494 |
08/25/2016 |
HQS Introducer (Model 2064-HQS) |
ALSEAL |
Jean-Francois M Delforge |
| K152931 |
08/29/2016 |
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator |
AMBU A/S |
LINE KAGENOW SVENSTRUP |
| K160766 |
08/17/2016 |
Ambu USR, Ambu M |
AMBU A/S |
CAMILLA WISMAR |
| K161405 |
08/19/2016 |
Valeo II Interbody Fusion Device System |
AMEDICA CORP. |
William D. Jordan |
| K160563 |
08/04/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
LIU YI |
| K160565 |
08/10/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
LIU YI |
| K153286 |
08/19/2016 |
iHealth Align Gluco-Monitoring system |
Andon health Co., Ltd |
Yi Liu |
| K153278 |
08/19/2016 |
Wireless Smart Gluco-Monitoring System |
Andon Health Co., Ltd |
Yi Liu |
| K151047 |
08/31/2016 |
MTA Repair HP |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
Paulo Sergio Calixto de Oliveria |
| K153200 |
08/09/2016 |
SnoreRx |
Apnea Sciences Corporation |
James Fallon |
| K160248 |
08/05/2016 |
ArgenIS Titanium Abutments |
Argen Corporation |
Paul Cascone |
| K161066 |
08/10/2016 |
SpotLight CT |
Arineta Ltd. |
Ehud Dafni |
| K153596 |
08/09/2016 |
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control |
ARK DIAGNOSTICS, INC. |
KENNETH C. KASPER |
| K161315 |
08/18/2016 |
Vein Clamps, Artery Clamps |
AROS Surgical Instruments Corporation |
Fred Phleps |
| K161313 |
08/24/2016 |
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
JULIE LAWSON |
| K161108 |
08/29/2016 |
Arthrex VaultLock Glenoid |
ARTHREX, INC. |
Courtney Smith |
| K162074 |
08/22/2016 |
Werewolf RF20000 Controller, FLOW 50 Wand |
ARTHROCARE CORPORATION |
SHIRLEY HYINK |
| K161126 |
08/25/2016 |
ASAHI Corsair Pro |
ASAHI INTECC CO., LTD. |
CARROLL COUNCILMAN |
| K160702 |
08/23/2016 |
ZION Anterior Cervical Fixation System |
Astura Medical |
TROY TAYLOR |
| K153551 |
08/04/2016 |
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. |
Axis-Shield Diagnostics Limited. |
Claire I Dora |
| K153297 |
08/12/2016 |
Perifix and Contiplex Catheter |
B. BRAUN MEDICAL INC |
LISA GIAQUINTO |
| K161986 |
08/04/2016 |
SIDEKICK and USHER Support Catheters |
BARD PERIPHERAL VASCULAR, INC. |
Melanie Hadlock |
| K153651 |
08/18/2016 |
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems |
BECKMAN COULTER, INC. |
MICHAEL ROBERT LORENZ |
| K161306 |
08/08/2016 |
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial |
BECTON DICKINSON |
ASHANTI C. BROWN |
| K161777 |
08/29/2016 |
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems |
Becton Dickinson Infusion Therapy Systems, Inc. |
Kimberly Geisler |
| K161286 |
08/04/2016 |
IPL Therapy Machine |
BEIJING ADSS DEVELOPMENT CO., LTD |
YURONG GAO |
| K161324 |
08/12/2016 |
Raycell Mk2 |
Best Theratronics Limited |
MIKE DE VAN DER SCHUEREN |
| K161211 |
08/29/2016 |
Digital Thermometer |
BIOCARE ASIA CORPORATION LTD. |
KE-MIN JEN |
| K153573 |
08/11/2016 |
Converge |
BIOMEDICAL ENTERPRISES, INC |
Joe Soward |
| K161896 |
08/02/2016 |
Biomet Microfixation Sternal Closure System |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K153205 |
08/01/2016 |
IDSS ForceTriad Control Module |
BLACK DIAMOND VIDEO, INC |
Ragunath Muniandy |
| K152125 |
08/15/2016 |
Oral Surgery System and Accessories |
BONART CO., LTD. |
BANKSON TSAI |
| K153742 |
08/08/2016 |
Apollo Balloon Dilatation Catheter |
BrosMed Medical Co., Ltd. |
Tina Yin |
| K153440 |
08/18/2016 |
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set |
C.R BARD, INC. |
Darlene Hull |
| K161130 |
08/24/2016 |
ResolutionMD |
CALGARY SCIENTIFIC, INC. |
Kyle Peterson |
| K161245 |
08/05/2016 |
EP-TRACER System |
CARDIO TEK, BV |
OLIVER ROTH |
| K160840 |
08/12/2016 |
ECG100+, ECG200+ |
CARDIOLINE S.p.A |
EMANUELE ERCOLI |
| K160764 |
08/25/2016 |
AirLife Autofill Humidification Chamber |
CAREFUSION 2200, INC. |
ERIKA FERNANDEZ |
| K160723 |
08/30/2016 |
OnSight 3D Extremity System |
CARESTREAM HEALTH, INC. |
Carolyn Wagner |
| K161033 |
08/03/2016 |
AFXÖ Femoral Implant With Inserter |
CAYENNE MEDICAL, INC. |
SHIMA HASHEMIAN |
| K161619 |
08/29/2016 |
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems |
Cepheid |
Scott A. Campbell |
| K161544 |
08/31/2016 |
Trojan Chain Reaction Personal Lubricant |
CHURCH & DWIGHT CO., INC. |
Lisa Burns |
| K161545 |
08/26/2016 |
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant |
CHURCH & DWIGHT CO., INC. |
Lisa Burns |
| K160806 |
08/05/2016 |
Verza Guidance System |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
Amanda Stahle |
| K153347 |
08/19/2016 |
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit |
CODMAN & SHURTLEFF, INC. |
Megan Herman |
| K152834 |
08/10/2016 |
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 |
COLONPLUS EQUIPMENTS & SPECULUMS, S.L. |
Jorge Echevarria |
| K161518 |
08/17/2016 |
PACS CORE/ENCORE |
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. |
Felipe Cuaranta Monroy |
| K153397 |
08/18/2016 |
S-Wire Guidewire System |
CONCERT MEDICAL, LLC |
Timothy S. Powers |
| K161100 |
08/10/2016 |
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses |
CONTAMAC LTD. |
ROB MCGREGOR |
| K160542 |
08/02/2016 |
5.0 Fr Arndt Endobronchial Blocker Set |
COOK INCORPORATED |
Kotei Aoki |
| K160219 |
08/03/2016 |
Hilal Embolization MicroCoils |
Cook Incorporated |
David Lehr |
| K160414 |
08/01/2016 |
Precision Point Biopsy Needle Guide |
Corbin Clinical Resources, LLC |
Kenneth K Kleinhenz |
| K160679 |
08/08/2016 |
WoundClot9 |
CORE SCIENTIFIC CREATION LTD. |
YUVAL YASKIL |
| K160331 |
08/12/2016 |
LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp |
Covidien |
Hong Zhu |
| K161105 |
08/18/2016 |
Reprocessed Compression Garments |
COVIDIEN |
WING NG |
| K160636 |
08/03/2016 |
iPEP System and vPEP |
D R BURTON HEALTHCARE LLC |
DENNIS COOK |
| K160281 |
08/04/2016 |
OSSIX PLUS |
Datum Dental Ltd. |
Arie Goldlust |
| K153549 |
08/04/2016 |
OSSIX VOLUMAX |
Datum Dental Ltd. |
Arie Goldlust |
| K160483 |
08/05/2016 |
Burn-out Cylinder and Angled Screw Abutments |
Dentium Co., Ltd |
Sangpil Yoon |
| K161030 |
08/26/2016 |
ATLANTIS Abutment for CONELOG implant |
Dentsply Sirona |
Helen Lewis |
| K160626 |
08/29/2016 |
ATLANTIS Abutment for HIOSSEN ET implant |
DENTSPLY SIRONA |
Helen Lewis |
| K161269 |
08/12/2016 |
CELTRA Press |
DENTSPLY SIRONA |
HELEN LEWIS |
| K153709 |
08/08/2016 |
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet |
DEVICOR MEDICAL PRODUCTS, INC. |
SHAWNA ROSE |
| K160650 |
08/25/2016 |
LIAISON HAV IgM, LIAISON Control HAV IgM |
DiaSorin Inc. |
John Walter |
| K151458 |
08/22/2016 |
Double Medical Universal Spine System |
Double Medical Technology Inc |
DA ZENG |
| K160275 |
08/01/2016 |
Fuse Endoscopic System with FuseBox Processor |
EndoChoice Inc. |
Daniel Hoefer |
| K161199 |
08/01/2016 |
EndyMed Contour Handpiece |
ENDYMED MEDICAL LTD. |
Yoram Levy |
| K161663 |
08/23/2016 |
sTMS mini |
ENEURA INC |
CYNTHIA MERRELL |
| K162152 |
08/31/2016 |
ErbeÆs CO2 Tubing/Cap Sets |
Erbe USA, Inc. |
John Tartal |
| K161513 |
08/25/2016 |
Anti-Borrelia burgdorferi US Westernblot (IgG) |
EUROIMMUN US |
MICHAEL LOCKE |
| K153303 |
08/10/2016 |
EUROIMMUN Anti-West Nile Virus ELISA (IgG) |
EUROIMMUN US, INC. |
Michael Locke |
| K153308 |
08/12/2016 |
EUROIMMUN Anti-West Nile Virus ELISA (IgM) |
EUROIMMUN US, INC. |
Michael Locke |
| K153649 |
08/31/2016 |
Exactech« Novation« Element Press-fit Femoral Stem |
EXACTECH INC |
Thomas McNamara |
| K161266 |
08/11/2016 |
Athena Breast Pump |
EXPLORAMED NC7, INC |
JOHN CHANG |
| K153243 |
08/04/2016 |
Fehling-Punches |
Fehling Instruments GmbH & Co. KG |
Ulrike Lindner |
| K161877 |
08/05/2016 |
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tam |
FIRST QUALITY HYGIENIC, INC. |
Melanie Leibowitz |
| K160797 |
08/26/2016 |
FMX314 Surgical Platform |
Fortimedix Surgical B.V. |
DIRKJAN BAKKER |
| K162045 |
08/18/2016 |
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System |
FUJIFILM SonoSite, Inc. |
Jordan Grimmer |
| K161516 |
08/25/2016 |
G Surgical Marksman MIS System |
G SURGICAL LLC |
Donald Grafton |
| K160338 |
08/05/2016 |
Triton System |
GAUSS SURGICAL INC. |
ARTIE KAUSHIK |
| K160937 |
08/01/2016 |
Senolris |
GE Healthcare |
Mounir Zaouali |
| K161224 |
08/05/2016 |
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 |
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
Tracey Ortiz |
| K161588 |
08/31/2016 |
Vscan Extend |
GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
Tracey Ortiz |
| K161706 |
08/05/2016 |
Vivid iq |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L |
Tracey Ortiz |
| K161574 |
08/11/2016 |
Discovery MI |
GE Medical Systems, L.L.C. |
Helen Peng |
| K161397 |
08/31/2016 |
MAGiC |
GE Medical Systems, LLC |
Mary A. Mayka |
| K162052 |
08/18/2016 |
Sentinella 102, Sentinella 102 Horus |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
JOSE MONTES |
| K161502 |
08/16/2016 |
MC1 Plus |
GENERAL PROJECT S.R.L. |
MORENO NALDONI |
| K161914 |
08/09/2016 |
Genesys Spine TiLock Cortical Spinal System |
Genesys Spine |
William W. Sowers |
| K161791 |
08/11/2016 |
Aer-O-Scope Colonoscope System |
GI View Ltd. |
Sharon Goldfarb |
| K160597 |
08/29/2016 |
INDEPENDENCE MIS Spacers |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K160138 |
08/11/2016 |
Adhesive Electrodes |
GMDASZ MANUFACTURING CO., LTD |
CHARLES MACK |
| K161376 |
08/25/2016 |
DragonFly Surgical Drill System |
Grace Medical, Inc. |
William Graham |
| K160664 |
08/01/2016 |
Aqueduct 100 Cervical Dilator |
GTIMD LLC |
RICHARD DEMELLO |
| K161615 |
08/23/2016 |
Accurett |
H&O EQUIPMENTS, NV/SA |
Aline Franck |
| K161251 |
08/30/2016 |
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests |
Hangzhou Clongene Biotech Co., Ltd |
Zheng Shujian |
| K160999 |
08/01/2016 |
Infra-red forehead thermometer |
HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD |
AHNEO YANG |
| K160802 |
08/24/2016 |
Infrared Forehead Thermometer, FT-100A |
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. |
JIAQIANG WAN |
| K160560 |
08/04/2016 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K161006 |
08/04/2016 |
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove |
HARTALEGA SDN. BHD. |
KUAN KAM HON |
| K152949 |
08/17/2016 |
WebPAX |
HEART IMAGING TECHNOLOGIES, LLC |
Robert Judd |
| K161772 |
08/24/2016 |
FFRct |
HEARTFLOW, INC. |
Windi Hary |
| K151542 |
08/03/2016 |
A-Oss |
HIOSSEN INC. |
David Kim |
| K152126 |
08/17/2016 |
UST-5550-R; UST-5536-R; L43K |
HITACHI ALOKA MEDICAL AMERICA, INC. |
ANGELA VAN ARSDALE |
| K161748 |
08/17/2016 |
SUPRIA w/guideShot Option |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K161575 |
08/10/2016 |
Affirm Lateral Arm Upright Biopsy Accessory |
HOLOGIC |
DEBBIE PEACOCK |
| K160022 |
08/17/2016 |
LUOFUCON Silicone Ag foam dressing |
HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. |
Guosheng Tan |
| K161148 |
08/09/2016 |
icobrain |
Icometrix |
Dirk Loeckx |
| K153756 |
08/04/2016 |
Microlyte Ag |
IMBED BIOSCIENCES, INC. |
ANKIT AGARWA |
| K151757 |
08/03/2016 |
IMMEDIATELOAD Dental Implant System |
IMMEDIATELOAD S.A. |
GIOVANNI CANINO |
| DEN150037 |
08/22/2016 |
ImPACT Computerized Neurocognitive Concussion Management Aid |
IMPACT APPLICATIONS, INC. |
MICHAEL ZAGORSKI |
| K153509 |
08/26/2016 |
GPS Angled Abutment |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
DEBLEENA SINHA |
| K160329 |
08/19/2016 |
InMode System MiniFX Handpiece |
InMode MD Ltd. |
Amit Goren |
| K161189 |
08/25/2016 |
Integra TITAN Reverse Shoulder System |
INTEGRA LIFESCIENCES CORPORATION |
William Garzon |
| K153276 |
08/07/2016 |
da Vinci Xi Surgical System |
INTUITIVE SURGICAL, INC. |
Brandon Hansen |
| K161355 |
08/25/2016 |
invendoscopy E200 System |
Invendo Medical GmbH |
Oliver V. Ruepprecht |
| K162001 |
08/31/2016 |
1.5T and 3.0T 16 CH GE Shoulder Coils |
INVIVO CORPORATION |
KEN REVENNAUGH |
| K152224 |
08/09/2016 |
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) |
ION BEAM APPLICATION S.A. |
ANNE-SOPHIE GRELL |
| DEN140040 |
08/01/2016 |
Nautilus BrainPulse 1000 |
JAN MEDICAL, INC. |
Paul Lovoi |
| K161864 |
08/02/2016 |
ARIX Foot System |
JEIL MEDICAL CORPORATION |
SEJIN RYU |
| K152091 |
08/18/2016 |
Fingertip Pulse Oximeter |
Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd |
Li Xu |
| K152089 |
08/17/2016 |
Wrist Pulse Oximeter |
Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd |
Li Xu |
| K160284 |
08/03/2016 |
JointPoint |
JOINTPOINT, INC. |
Noah D. Wollowick |
| K161098 |
08/22/2016 |
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) |
JOOWON INNOVATION CO., LTD. |
LEE HAE-HANG |
| K160675 |
08/02/2016 |
Powder free vinyl patient examination glove, colored (yellow) |
KAIXING PLASTIC PRODUCTS CO., LITD. |
Dan ny |
| K161933 |
08/16/2016 |
The Braun ThermoScan« 3 High Speed Compact Ear Thermometer |
Kaz USA, Inc., A Helen of Troy Company |
AMY LIU |
| K153364 |
08/19/2016 |
Kerecis SecureMesh |
Kerecis Limited |
Gudmundur Fertram Sigurjonsson |
| K151824 |
08/02/2016 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested |
KOSSAN INTERNATIONAL SDN. BHD. |
CHO SOW FONG |
| K151750 |
08/03/2016 |
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile |
KOSSAN INTERNATIONAL SDN. BHD. |
CHO SOW FONG |
| K160467 |
08/02/2016 |
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim |
Kossan International Sdn. Bhd. |
Cho Sow Fong |
| K153476 |
08/23/2016 |
KATANA AVENCIA Block |
Kuraray Noritake Dental, Inc. |
Michio Takigawa |
| K161766 |
08/22/2016 |
PathLoc-L MIS Spinal System |
L&K BIOMED Co., Ltd. |
Yerim An |
| K161570 |
08/29/2016 |
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large |
LC Medical Concepts, Inc. |
Dana M. Ledgerwood |
| K152642 |
08/26/2016 |
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode |
LCCS PRODUCTS LIMITED |
JAMES LIN |
| K161798 |
08/04/2016 |
FacetBRIDGE« System |
LDR SPINE USA, INC. |
JAMIE WILSON |
| K161037 |
08/15/2016 |
Tarsa-Link Stand-Alone Wedge Fixation System |
LIFE SPINE INC. |
RANDY LEWIS |
| K153065 |
08/01/2016 |
The Hammertoe Correction System |
LIFE SPINE, INC |
Randy Lewis |
| K160011 |
08/22/2016 |
H-Max S stem |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K161220 |
08/02/2016 |
ARIES« Flu A/B & RSV Assay |
LUMINEX CORPORATION |
WENDY RICKER |
| K161195 |
08/25/2016 |
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) |
M3 GLOBAL ENTERPRISES, LLC |
NEIL MEHTA |
| K161026 |
08/09/2016 |
NexSiteÖ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) |
MARVAO MEDICAL DEVICES, LTD. |
Christopher Davey |
| K162119 |
08/29/2016 |
UreTron PF Series Probe |
MED-SONICS CORP. |
JENNIFER RAUTINE |
| K153329 |
08/04/2016 |
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis |
MED-TECH WATER SYSTEMS INC |
BRIAN C KIM |
| K152659 |
08/25/2016 |
V10 |
MEDIANA CO., LTD |
KIM MIN HYE |
| K161249 |
08/19/2016 |
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead |
Medtronic |
Debra Taitague |
| K160983 |
08/24/2016 |
Kyphon HV-R Bone Cement |
MEDTRONIC INC |
PAMELA EDWARDS |
| K161210 |
08/12/2016 |
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems |
Medtronic Sofamor Danek |
Ankit K. Shah |
| K161287 |
08/19/2016 |
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak |
MEDTRONIC VASCULAR |
Nisarg Shah |
| K161402 |
08/18/2016 |
Bullfrog Micro-Infusion Device |
MERCATOR MEDSYSTEMS, INC. |
Kirk P. Seward |
| K161409 |
08/02/2016 |
M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem |
Mermaid Medical A/S |
Pia Wissing Jensen |
| K160699 |
08/01/2016 |
VIRTU Lumbar Spacer System |
Met 1 Technologies, LLC |
Dan Gerbec |
| K153285 |
08/12/2016 |
EMS-200 |
META SYSTEMS CO., LTD. |
RAY JEON |
| K161292 |
08/15/2016 |
Distal Radius Plating System |
MIAMI DEVICE SOLUTIONS, LLC |
MARKKU BIEDERMANN |
| K153283 |
08/11/2016 |
VivoSight Dx Topical OCT System |
Michelson Diagnostics Ltd |
Martin Johns |
| K162077 |
08/11/2016 |
Laparoscopic Spray Applicator with Spinning Luers |
MICROMEDICS INC. (D/B/A NORDSON MEDICAL) |
AMY L. PETERSON |
| K161367 |
08/31/2016 |
HydroCoil Embolic System (HES) |
MICROVENTION, INC. |
SAPNA SINGH |
| K161452 |
08/31/2016 |
MicroPlex Coil System (MCS) - HyperSoft 3D |
MICROVENTION, INC. |
SAPNA SINGH |
| K160149 |
08/30/2016 |
Miret Grasper, Alligator, Miret Grasper, Maryland |
MIRET SURGICAL INC. |
AVI ROOP |
| K160379 |
08/25/2016 |
Exufiber Ag+ |
MOLNLYCKE HEALTH CARE, US LLC |
MEGAN BEVILL |
| K160685 |
08/04/2016 |
Surveyor S4 Mobile Monitor |
Mortara Instrument, Inc. |
Sarah Weber |
| K152289 |
08/17/2016 |
Alians Elbow Locking Plating System |
NEWCLIP TECHNICS |
Gaelle LUSSORI |
| K162075 |
08/11/2016 |
NICO TRIOwand |
NICO Corporation |
Sean Spence |
| K160865 |
08/05/2016 |
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S |
NONIN MEDICAL, INC. |
NANCY E. DEANGELO |
| K161230 |
08/25/2016 |
NuVasive Lumbar Interbody Implants |
NUVASIVE, INCORPORATED |
MARTIN YAHIRO |
| K152890 |
08/11/2016 |
SACCADOMETER PLUS, SACCADOMETER ADVANCED |
OBER CONSULTING SP. Z.O.O. |
JAN KRZYSZTOF OBER |
| K161034 |
08/19/2016 |
Microcyn Plus Wound Care Solution |
OCULUS INNOVATIVE SCIENCES |
BRIAN W. MARTIN |
| K161622 |
08/11/2016 |
LensGiene Sterile Saline Solution |
Optics Laboratory, Inc. |
Patricia Chiu |
| K150830 |
08/26/2016 |
CompleClear Plastic Orthodontic Bracket and Wire Appliance |
ORACREW |
PAWAN GAUTAM |
| K161267 |
08/11/2016 |
Response BandLoc Spinal Fixation |
ORTHOPEDIATRICS CORP. |
MARK FOX |
| K161505 |
08/03/2016 |
DyeVert NG Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K160611 |
08/08/2016 |
P-ARTIS |
P-CURE LTD. |
MICHAEL MARASH |
| K161019 |
08/17/2016 |
Uroview FD |
PAUSCH MEDICAL GMBH |
Christian Stoian |
| K153678 |
08/08/2016 |
PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove |
PERMEADERM, INC. |
AUBREY WOODROOF |
| K161532 |
08/29/2016 |
Philips Avent Comfort Single/Twin Electric Breast Pump |
Philips Consumer Lifestyle-Innovation Site Eindhoven |
Marta Walker |
| K160743 |
08/08/2016 |
Philips Ingenuity CT |
Philips Medical Systems (Cleveland), Inc. |
Susan Quick |
| K160455 |
08/25/2016 |
AneurysmFlow |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
Jeanette Becker |
| K160147 |
08/10/2016 |
CT TrueView |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
JEANETTE BECKER |
| K161498 |
08/22/2016 |
Streamline OCT Occipito-Cervico-Thoracic System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K153514 |
08/22/2016 |
Premium Plus C01/C02 LED Curing Light |
PREMIUM PLUS INTERNATIONAL LIMITED |
Jessica Mao |
| K162196 |
08/15/2016 |
Dell UP3216Q with QUBYX PerfectLum bundle |
QUBYX SOFTWARE TECHNOLOGIES INC. |
MARC LEPPLA |
| K161182 |
08/15/2016 |
Solana Trichomonas Assay |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K160382 |
08/11/2016 |
OT EQUATOR |
RHEIN'83 SRL |
CLAUDIA NARDI |
| K160943 |
08/26/2016 |
Bite Away |
Riemser Pharma |
Ronny Raasch |
| K160944 |
08/31/2016 |
ACCU-CHEK Guide Blood Glucose Monitoring System |
Roche Diabetes Care, Inc. |
Khone Saysana |
| K153540 |
08/04/2016 |
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators |
SAFE SECURE PACKAGING CO., LTD |
HOWARD JIA |
| K162094 |
08/26/2016 |
RS80A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd |
Kyeong-Mi Park |
| K161955 |
08/10/2016 |
5D Viewer |
SAMSUNG Medison Co., Ltd. |
Kyeong-Mi Park |
| K152471 |
08/04/2016 |
CAPO BULK FILL |
SCHUETZ DENTAL GMBH |
Anke Puent |
| K161234 |
08/03/2016 |
CASSI II Rotational Core Biopsy System |
Scion Medical Technologies, LLC |
Louis Li |
| K152390 |
08/18/2016 |
Medke Oximetry Finger Sensor |
Shenzhen Medke Technology Co., LTD |
Lao Chengxin |
| K160932 |
08/01/2016 |
8ch Foot Ankle Coil |
Shenzhen RF Tech Co., Ltd. |
Ke Xi |
| K160106 |
08/26/2016 |
LUNA DENTAL IMPLANT SYSTEM |
SHINHUNG MST Co., Ltd |
Sunbyung Lee |
| K161196 |
08/24/2016 |
SOMATOM Drive |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K152197 |
08/26/2016 |
Skypro, SP01 Mask |
Skypro Medical Supplies Company |
Cyrus Wong |
| K161289 |
08/03/2016 |
DURAFIBER Ag |
SMITH & NEPHEW MEDICAL LIMITED |
Samantha Neilson |
| K153209 |
08/04/2016 |
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply |
SMITH & NEPHEW MEDICAL LTD. |
LAURA REYNOLDS |
| K162129 |
08/31/2016 |
RENASYS-G Gauze Dressing Kits with Soft Port |
Smith & Nephew, Inc. |
Laura Reynolds |
| K153274 |
08/04/2016 |
Med-Tainer Single Deposit Container |
Snyder Industries, Inc. |
Herbert H Spann |
| K162030 |
08/19/2016 |
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle |
SOL-MILLENNIUM MEDICAL, INC |
JIM BARLEY |
| K160472 |
08/10/2016 |
Hidrocor, Hidrocharme, and Natural Colors |
SOLOTICA |
Gilberto Zablith |
| K161396 |
08/17/2016 |
SPEC Model M23 |
Source Production and Equipment Co.,Inc. |
Kelley Richardt |
| K153352 |
08/01/2016 |
Vertu« & Vertu« Ti-Bond and Crystal« & Crystal« Ti-Bond Cervical Interbody System |
Spinal Elements Inc. |
Cecilia Silva |
| K160856 |
08/01/2016 |
SpineView X-Pac Expandable Lumbar Cage System |
Spine View, Inc. |
Mbithi Muthini |
| K161387 |
08/04/2016 |
Mont Blanc and Mont Blanc MIS Spinal Systems |
SPINEWAY S.A. |
NICOLAS ROTH |
| K161171 |
08/15/2016 |
PressureWire X Guidewire |
ST. JUDE MEDICAL INC. |
HUDA YUSUF |
| K153706 |
08/29/2016 |
Insulin Pen Needle |
STERILANCE MEDICAL (SUZHOU) INC. |
Juanjuan Sun |
| K161683 |
08/05/2016 |
SYSTEM 1E Liquid Chemical Sterilant Processing System |
STERIS CORPORATION |
Tricia Cregger |
| K160600 |
08/26/2016 |
Freedom Spinal Cord Stimulator System |
STIMWAVE TECHNOLOGIES INCORPORATED |
Elizabeth Greene |
| K161311 |
08/29/2016 |
USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles |
STRUKMYER MEDICAL LLC |
ROBERT DELK |
| K160612 |
08/17/2016 |
Sumitomo Proton Therapy System |
SUMITOMO HEAVY INDUSTRIES, LTD |
KATSUHIRO NARASAKI |
| K160097 |
08/05/2016 |
Image Fast Set, Image Regular Set |
Sybron Dental Specialties |
Gerardo Lara |
| K160787 |
08/09/2016 |
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet |
SYNCRO MEDICAL INNOVATIONS, INC. |
Sabry Gabriel |
| K160938 |
08/01/2016 |
SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens |
SynergEyes, Inc. |
James Kirchner |
| K153470 |
08/19/2016 |
MADgic Laryngo-Tracheal Mucosal Atomization Device |
TELEFLEX MEDICAL |
Kristen Bisanz |
| K153089 |
08/12/2016 |
'cottony' II TAPE, PLEDGETS |
Teleflex Medical, Inc. |
Natalie Hichak |
| K161092 |
08/23/2016 |
GalaSHAPE 3D |
Tepha, Inc. |
Connie H Garrison |
| K153560 |
08/25/2016 |
Optilite Low Level Albumin Kit |
THE BINDING SITE GROUP LTD |
JON LAUDER |
| K161661 |
08/12/2016 |
Thermi RF Accessories |
THERMI |
Carrie Eddings |
| K160592 |
08/12/2016 |
SUPERCATH 6 |
TOGO MEDIKIT CO., LTD. |
Daisuke Nagamizu |
| K160615 |
08/26/2016 |
ORTHODONTIC CERAMIC BRACKETS 1.1 |
TOMY, INC |
JINICHI WATANABE |
| K160366 |
08/19/2016 |
Electrosurgical disposable grounding pads |
TOP-RANK Health Care Co., Ltd |
Liubo Shen |
| K153452 |
08/11/2016 |
Salto XT, Salto Talaris |
Tornier SAS |
SΘverine BONNETON |
| K160632 |
08/23/2016 |
Vantage Titan 1.5T, MRT-1510, V3.6 Software |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K161331 |
08/23/2016 |
HyperSound Tinnitus Module |
TURTLE BEACH CORPORATION |
JAMES A. BARNES |
| K162189 |
08/30/2016 |
ANAXÖ 5.5 Spinal System |
U&I Corporation |
Ji Yea Lee |
| K160648 |
08/10/2016 |
MiniMed Quick-Set« MiniMed Sure-T« MiniMed Silhouette« MiniMed Mio« |
UNOMEDICAL A/S |
John M Lindskog |
| K160516 |
08/10/2016 |
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K161336 |
08/11/2016 |
VSI StraitSet micro-introducer kit |
VASCULAR SOLUTIONS, INC. |
ADAM ETTL |
| K161113 |
08/05/2016 |
QXLink |
VIEWORKS CO., LTD. |
YOONJAE IM |
| K161124 |
08/26/2016 |
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear |
VISION SCIENCE CO.,LTD. |
OH IN-WHAN |
| K160253 |
08/26/2016 |
Vitalograph Model 6300 micro |
VITALOGRAPH (IRELAND) LTD. |
TOM J HEALY |
| K160774 |
08/03/2016 |
IonoStar Plus |
VOCO GMBH |
M. TH. PLAUMANN |
| K160793 |
08/17/2016 |
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) |
W.H.P.M., INC. |
John Wan |
| K153478 |
08/15/2016 |
Sydney IVF Gamete Buffer |
WILLIAM A. COOK AUSTRALIA PTY LTD |
Gordana Pozvek |
| K161385 |
08/17/2016 |
Just Like Me Personal Lubricant |
WTFN-dba Classic Erotica/Holiday Products |
Christina Zaragoza |
| K161503 |
08/26/2016 |
ORION |
YERIM ENGINEERING Co., Ltd. |
Won Gil Jeon |
| K153193 |
08/30/2016 |
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) |
ZYNO MEDICAL LLC |
Mei Zhang |
